NCT03933930

Brief Summary

Hyperthermic intraperitoneal chemotherapy is a major surgery for tumor peritoneal metastasis. For anesthesiologist, the intra-operative fluid control is always a big challenge. We try to compare the prognosis of lactate-directed and goal-directed therapy. We expect to confirm the better prognosis of lactate-directed therapy.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2019

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

2 years

First QC Date

April 12, 2019

Last Update Submit

May 31, 2020

Conditions

Organ Failure, Multiple

Outcome Measures

Primary Outcomes (1)

  • pulmonary complication

    X-ray findings of airspace or interstitial opacity, lobar consolidation, or pleural effusions; severe respiratory failure requiring respiratory support

    1 week

Secondary Outcomes (1)

  • Renal complication

    1 week

Study Arms (2)

Lactate-directed therapy

EXPERIMENTAL
Other: Lactate-directed therapyOther: Goal-directed therapy

Goal-directed therapy

EXPERIMENTAL
Other: Goal-directed therapy

Interventions

Lactate-directed therapyOTHER

If the lactate level elevates, we transfuse pRBC to increase Hct\>30%. If Hct \>30%, dopamine infusion starts.

Lactate-directed therapy
Goal-directed therapyOTHER

If SVV\>15%, transfuse lactate ringer/normal saline alternatively to keep SVV\<15%.

Goal-directed therapyLactate-directed therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving hyperthermic intraperitoneal chemotherapy

You may not qualify if:

  • Unable to set arterial line Severe liver or renal disease Severe heart disease Unconscious patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Critical CarePatient CareTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2019

First Posted

May 1, 2019

Study Start

May 6, 2019

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share